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EC number: 237-732-7 | CAS number: 13952-84-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study, similar to OECD Test Guidelines with acceptable deviations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
- Deviations:
- yes
- Remarks:
- Dosing of females only until gd 21 No information on termination of male rats, no dosing during lactation until weaning; pathology of P-generation limited?
- GLP compliance:
- yes
- Justification for study design:
- four groups of 20 male and 25 female rats
each were exposed for 6 hrs/day, 5 days/wk
(except holidays) for approximately 10.5 weeks.
Each exposed male was then consecutively
cohoused (1:1) with two unexposed females;
exposed females were cohoused (1:1) with
unexposed males. Treated males and females
were exposed during the mating period
(5 days/wk). Once mating occurred, treated
females were exposed 7 days/wk through
gestation day 20. Untreated female mates of exposed males were terminated approximately two weeks
after copulation to assess fertility. Exposed females were
housed in delivery boxes and delivered their pups. Pups were
weaned on lactation Day 21 and necropsied. Mean analytical
exposure concentrations were 20, 100, and 499 mg IPA per cubic
meter.
Test material
- Reference substance name:
- Isopropylamine
- EC Number:
- 200-860-9
- EC Name:
- Isopropylamine
- Cas Number:
- 75-31-0
- Molecular formula:
- C3H9N
- IUPAC Name:
- propan-2-amine
- Details on test material:
- - Name of test material (as cited in study report): Isopropylamine (2-aminopropane)
- Substance type: organic
- Physical state: clear liquid
- Analytical purity: 99.77 %
- Lot/batch No.: LP-606
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: (P) 54 d wks; (F1) x wks
- Weight at study initiation: (P) Males: 241 - 300 g; Females: 163 - 207 g
- Fasting period before study:
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- air
- Details on mating procedure:
- - M/F ratio per cage: 1:1
- Length of cohabitation: maximally 7 d
- Proof of pregnancy: vaginal plug / sperm in vaginal smear referred to as [day 0 / day 1] of pregnancy
- Female reproduction (males unexposed): After 7 days of unsuccessful pairing replacement of first male by another male with proven fertility.
- Male fertility (females unexposed): After 7 days of unsuccessful pairing replacement of first female by another unexposed female - Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- - Duration of test: up to 15 weeks (males)
- Duration of test: 17-18 weeks (females) - Frequency of treatment:
- untreated + treated males: Six hours per day, 5 days per week
treated and untreated females: Six hours per day, 5 days per week (premating and mating period)
treated females: Six hours per day, 7 days per week (during gestation period)
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
20, 100, and 499 mg/m3
Basis:
analytical conc.
- Distribution: range 1.8-10% - Stability: range 11-15%
- Remarks:
- Doses / Concentrations:
21, 109 and 526 mg/m3
Basis:
nominal conc.
average
- Dose / conc.:
- 20 mg/m³ air (analytical)
- Dose / conc.:
- 100 mg/m³ air (analytical)
- Dose / conc.:
- 499 mg/m³ air (analytical)
- No. of animals per sex per dose:
- Twenty male rats per treatment
- Twenty-five female rats per treatment - Control animals:
- yes
Examinations
- Parental animals: Observations and examinations:
- ADMINISTRATION / EXPOSURE:
- Premating period: 10.5 weeks
- Route of administration: inhalation
- Post exposure period: from day 21 of gestation until day 21 of lactation
- Exposure duration: 6 hours/day, 5 days/week (after mating 7 days/week until day 20 of gestation)
- Preparation of particles: using a Laskin-style nebulizer
- Air changes: 12/hour
STANDARDIZATION OF LITTERS:
- On day 4 of lactation litters were culled to 4 pups/sex
PARAMETERS ASSESSED IN PARENTS:
- Detailed observations and body weight were assessed on a weekly basis
- Mortality/clinical observations: daily during and after exposure
- Body weight females: weekly until mating, thereafter on day 0, 6, 13 and 20 of gestation and on day 0, 4, 7,
14 and 21 of lactation
- Number of live pups at delivery
- After termination, females were examined and the number of implantations and the number of corpora lutea
were determined
ORGANS EXAMINED AT NECROPSY (MACROSCOPIC AND MICROSCOPIC):
- Gross necropsy of dams and pups on day 21 of lactation
- Histopathology on tissues of pups of control and high dose group - Litter observations:
- OFFSPRING:
- Body weight: day 0, 4, 7 and 14 of lactation (litter weight by sex) and on day 21 (individual weights)
- External examination on day 0, 4, 7, 14 and 21 of lactation
ORGANS EXAMINED AT NECROPSY (MACROSCOPIC AND MICROSCOPIC):
- Gross necropsy of dams and pups on day 21 of lactation
- Histopathology on tissues of pups of control and high dose group - Statistics:
- - Dunnett's test, (uncorrected) chi-square test
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- incidentally fur discolouration and focal hair loss (not treatment-related)
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- In males during the majority of the study, no significant effects in females
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- In males during the majority of the study, no significant effects in females
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- not examined
- Description (incidence and severity):
- Test substance intake: not applicable (inhalation)
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
Details on results (P0)
- Two males in the high dose group died (week 1 and first week of mating)
- Males in the high dose group had a significantly lower body weight during the majority of the study
- No significant differences appeared in mating and fertility parameters
- Maternal mortality: none
- Body weight: no treatment related effects
- Clinical signs: incidentally fur discolouration and focal hair loss (not treatment-related)
- Mating success: 23/25, 25/25, 23/25 and 25/25 at 0, 20, 100 and 500 mg/m3, respectively
- Number pregnant per dose level: 21, 19, 17 and 19 at 0, 20, 100 and 500 mg/m3, respectively
- Gestational length: 22-23 days
- Gross pathology incidence and severity: no treatment related effects
- The number of corpora lutea, implantations and resorptions was not affected by treatment
Effect levels (P0)
- Dose descriptor:
- NOAEC
- Remarks:
- (highest concentration tested)
- Effect level:
- 500 mg/m³ air
- Sex:
- male/female
- Basis for effect level:
- other: No significant effects on mating or fertility parameters
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
Details on results (F1)
- Mean litter size (day 21): 8, 8, 8 and 8 at 0, 20, 100 and 500 mg/m3, respectively
- Sex ratio: no treatment related effects
- Body weight (day 0): 6.3, 6.6, 6.5 and 6.2 g at 0, 20, 100 and 500 mg/m3, respectively
- Body weight (day 21): 55, 58, 57 and 56 g at 0, 20, 100 and 500 mg/m3, respectively
- External abnormalities: none
- Histopathology: no treatment related effects
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEC
- Remarks:
- (direct exposure: P-generation / indirect (intrauterine) exposure: embryos/foetus)
- Generation:
- F1
- Effect level:
- 500 mg/m³ air
- Sex:
- male/female
- Basis for effect level:
- other: based on neonatal and perinatal mortality and body weight
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No effects on mating or fertility parameters were observed in Sprague-Dawley rats after exposure to an aerosol of isopropylamine at analytical concentrations up to 499 mg/m^3, resulting in a NOAEL of 499 mg/m^3.
- Executive summary:
The purpose of these studies was to examine the toxicity of inhaled isopropylamine (IPA) in Sprague-Dawley rats and their offspring.
This project consisted of three studies: a male fertility study, a female reproduction study, and a subchronic toxicity study.
Animals in these three studies were exposed concurrently.
In the fertility and reproduction studies, four groups of 20 male and 25 female rats each were exposed for 6 hrs/day, 5 days/wk
(except holidays) for approximately 10.5 weeks. Each exposed male was then consecutively cohoused (1:1) with two unexposed females;
exposed females were cohoused (1:1) with unexposed males. Treated males and females were exposed during the mating period
(5 days/wk). Once mating occurred, treated females were exposed 7 days/wk through gestation day 20. Untreated female mates
of exposed males were terminated approximately two weeks after copulation to assess fertility. Exposed females were housed in delivery boxes and delivered their pups. Pups were weaned on lactation Day 21 and necropsied. Mean analytical exposure concentrations were 20, 100, and 499 mg IPA per cubic meter. The mean body weight of exposed high level males was significantly reduced throughout most of the study. There were no treatment-related effects on mating, fertility,or reproduction parameters in exposed males or females. No gross or microscopic pathology changes were noted in FO or F1 animals.
The following information is taken into account for any hazard / risk assessment:
NOAEC = 500 mg/m3: No adverse effect on reproductive performance in the P-generation and no adverse effects on development of the progeny of the P-generation (F1)
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